BMT ANSCORE HEALTH MANAGEMENT SYSTEM


Device Classification Name

electrocardiograph

510(k) Number K010955
Device Name BMT ANSCORE HEALTH MANAGEMENT SYSTEM
Original Applicant
BOSTON MEDICAL TECHNOLOGIES, INC.
591 north ave., suite 5
wakefield, 
MA 
01880 -1641

Original Contact cesidio tempesta
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 03/30/2001
Decision Date 04/26/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No